Bachelor's degree in Engineering or Technical Discipline.
4-5 years of experience in Manufacturing Engineering.
Expertise in Process Validation (IQ/OQ/PQ).
Experience in Test Method Validation (Gauge R&R).
Proficient with PLM and ERP/MRP Systems.
Strong background in Statistical Analysis and Manufacturing Documentation.
Responsibilities
Support the development and validation of new manufacturing processes.
Execute IQ/OQ/PQ Process Validations efficiently.
Perform Test Method Validation and Software Validation.
Manage Bill of Materials (BOMs) in PLM systems.
Integrate components into ERP/MRP systems seamlessly.
Create and maintain essential manufacturing documents including protocols and reports.
Troubleshoot production and quality issues on the manufacturing floor.
Benefits
Opportunities for professional development and continuing education.
Collaborative work environment with fellow experts.
Access to cutting-edge technology and innovative projects.
Potential for career advancement in a growing organization.
Full Job Description
Summary: Seeking a Sr Manufacturing Engineer to support implementation of design changes for medical device electronic hardware. The role focuses on process validation, test method validation, PLM/ERP management, manufacturing documentation, and production support.
Roles & Responsibilities:
Support development and validation of new manufacturing processes.
Execute IQ/OQ/PQ Process Validations.
Perform Test Method Validation (Gauge R&R) and Software Validation.
Manage BOMs and product configurations in PLM systems.
Integrate components into ERP/MRP systems.
Create and maintain:
Manufacturing Protocols & Reports
PFMEA
Manufacturing Instructions
Engineering Change Orders (ECOs)
Statistical Analysis Documentation
Support service depot documentation and BOM structures.
Troubleshoot production and quality issues on the manufacturing floor.
Required Qualifications:
Bachelor's degree in Engineering or Technical Discipline.
Minimum 4-5 years Manufacturing Engineering experience.
